It seems that panobinostat’s review by the U.S. Food and Drug Ad­min­is­tra­tion (FDA) may be on track after all.

A spokeswoman for Novartis (NYSE:NVS), the Swiss pharmaceutical company that is developing panobinostat ^[1] as a potential new myeloma therapy, has told The Beacon that, contrary to a Beacon report ^[2] published yesterday, there has not been a delay in the FDA’s review of the drug’s marketing application.

With panobinostat’s review proceeding according to the expected time­table, there need not be concern that the FDA has uncovered un­ex­pected issues with the drug.

Yesterday’s Beacon news article indicated that the FDA’s review of panobinostat may have hit a speed bump. Novartis submitted panobinostat’s application for FDA approval in March of this year, and the drug was granted priority review by the agency later in the spring (see related Beacon ^[3] news).

In the case of many new drug applications, priority review designation means that the FDA expects to reach a decision on the application within six months, instead of the 10-month timetable for “standard” reviews.

A six-month timetable would have meant a decision on panobinostat’s new drug application was due by early last week. Yet no news of a decision was announced last week by either Novartis or the FDA.

Thus, when the FDA yesterday filed a notice with the Federal Register that it was scheduling a meeting of its Oncologic Drugs Advisory Committee (ODAC) to review the drug in early November, there appeared to be confirmation that the drug’s review had been delayed.

Attempts by The Beacon to clarify the situation last week with representatives from Novartis failed to allay concerns about a potential delay in panobinostat’s review. A company spokeswoman told The Beacon at that time that Novartis was “not able to provide further information other than what has already been provided (and which is in the public domain).” She also indicated the company might provide further information about the matter in its October 28 quarterly earnings report.

Fortunately, the publication of The Beacon’s report yesterday has led to significantly more information from Novartis about the status of the panobinostat new drug application.

And the news appears to be good for myeloma patients, caregivers, and medical professionals hoping for the approval of a new myeloma therapy in the near future.

In the case of panobinostat, it turns out that the priority review designation implies an eight-month timetable for the drug’s review, for reasons explained in more detail below.

Thus, the FDA apparently has not delayed its review of the drug, so the timetable for the review need not raise concerns that the agency has uncovered any unexpected difficulties related to the drug.

Likewise, the meeting the agency has scheduled with the ODAC in early November falls within the relevant timetable for reviewing the drug. And, most importantly, an FDA decision about the new drug application can be expected by the end of November (as also was suggested in yesterday’s Beacon article).

Why The Revised Estimate Of The Review Timetable?

Earlier today, a Novartis spokeswoman clarified in a phone discussion with The Beacon that, because panobinostat is considered by the FDA to be a “new molecular entity,” the drug’s priority review designation means its target review timetable consists of two parts: two months to initially review the application, and an additional six months to further review and make a decision on the application.

This means the drug’s total target review time is eight months, implying that a decision on its marketing application is due by the end of November – not, as it initially appeared, the end of September.

The Beacon also confirmed the review timetable information provided by Novartis with an FDA media representative. Although FDA personnel cannot discuss the specifics of a particular new drug application, an agency representative was able to confirm that, in the case of new drug applications involving a new molecular entity, a priority review designation does imply a target review timetable of eight months.

The Beacon will provide additional information about panobinostat’s upcoming ODAC meeting when more details become available, including information about FDA staff reports prepared for the meeting and the outcome of the meeting itself.